GxP Lifeline

Making the Business Case for Implementing an Electronic QMS

In a tough economy, quality professions often find themselves having to convince management that swapping their paper-based QMS for an electronic one is worthy of the expense and will translate into bottom-line, as well as compliance, benefits. While the regulatory and legal drivers for automating your quality processes are irrefutable, the frequently overlooked operational and business opportunities enjoyed by organizations that implement an electronic QMS are equally compelling. Simply put: compliance is good for business, and the right QMS software can help you transform your compliance challenges into tangible business advantages. Study Shows QMS Software Has Become a Top Priority in Best-in-Class Companies

QMS software is becoming commonplace in best-in-class organizations. According to AMR Research, quality management has moved from an afterthought to a strategic priority, topping the list as the most important software component in supply chain risk visibility. (1) What’s prompting the increased demand? No doubt it’s the intense and mounting scrutiny from the FDA, EMA, ISO, and other global regulatory agencies. But regulatory pressure isn’t the only thing keeping CEOs, CFO, and other senior executives up at night. Here are some commercial advantages to automating your quality processes, such as document control, employee training records, corrective action, and risk management, that will resonate strongly with senior management and stakeholders.

Competitive Advantages of QMS Software

You’ll save time—and lots of it: Manual or paper-based quality management systems are time-consuming, inefficient, and error-prone. These issues are compounded when your teams or suppliers are geographically dispersed, which is quite common in today’s global business environment By making data available across the enterprise in an easy-to-access central repository, and allowing employees to view the information in real time, compliance simply becomes an everyday part of doing business—and a roadmap to an efficient, effective organization.

You’ll become more agile: Being agile means being able to respond swiftly and adequately to change, which is inevitable in business, particularly for a company that operates in a highly regulated environment. Your quality management system must be able to handle changes from a wide variety of sources such as quality process improvements, customer feedback, product or service revisions, and changes in regulations or compliance. Implementing change in a paper-based system can be a long and tedious endeavor, but an electronic QMS can streamline the entire change control process. Geographically dispersed employees or virtual teams are able to access documents, enter data, and initiate changes from any location, allowing for faster turnaround.

You’ll deliver safer, higher quality products to your customers: Gaining a competitive advantage is only part of the appeal of an electronic QMS. Managers in best-of-breed life sciences and manufacturing companies are realizing that robust QMS solutions also support the next generation of quality management, which views improving product safety and efficacy as important as satisfying regulatory requirements. Automating your quality processes will help you produce and deliver higher quality products to your customers.

You’ll increased customer attraction and retention: As consumers become more sophisticated and demanding, and competition continues to increase, only organizations that are able to demonstrate and sustain product superiority will be able to win sales and retain customers.

Benefit or Burden?

Regulatory requirements are not going away; if anything, they’re increasing. Whether you manufacture drugs, medical devices, or automobiles, complying with existing and pending regulations directly impacts your bottom line. While many regulated companies view compliance as a bureaucratic burden, more and more companies are beginning to see it as a real competitive advantage; an advantage that can be accelerated with the right QMS software. When trying to secure buy-in at your organization, remember to point out the cost and operational efficiencies that automating your quality processes will afford rather than just the need for compliance.

Lisa Weeks is a marketing communications specialist at MasterControl Inc., writes extensively about technology, the life sciences industry, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.